The proposed changes only affect devices used to treat pelvic organ prolapse, but not stress urinary incontinence. Manufacturers would no longer be allowed to put new vaginal mesh products on the market through the 510(k) process, which allows similar devices to be approved without independent safety data. Instead, “high-risk” medical devices can only be cleared with safety data.

According to William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health:

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

FDA action began in July 2011, when the agency warned that serious complications were “not rare.” Two months later, an advisory panel recommended re-classifying the devices as “high-risk.” In January 2012, the FDA ordered manufacturers to conduct post-market surveillance studies to address concerns about safety and effectiveness of vaginal mesh.

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Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

"Collen's amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas."